A new clinical trial is preparing to investigate the potential preventative and therapeutic effects of a Bacillus spore probiotic oral spray on dental caries in children. Sponsored by Anabio R&D and Hanoi Medical University, this trial aims to evaluate the efficacy of Smile Care, a proprietary combination product, in improving oral health outcomes, as compared to a standard 0.9% NaCl physiological saline solution. The study has yet to begin recruitment, but it promises to bring innovative insights into pediatric dental care.
What is the study about?
The upcoming study will explore the role of probiotic oral sprays in managing dental caries in children—a common issue that affects oral health worldwide. Dental caries is caused by bacterial activity, which leads to demineralization and decay of tooth structures. Researchers are particularly interested in Smile Care, which contains Bacillus spore probiotics, as a novel approach to address these challenges.
What are the key details of this trial?
The trial will involve comparison between Smile Care and a 0.9% NaCl physiological saline solution. While Smile Care is designed to introduce beneficial microorganisms to the oral biome, saline solution serves as a baseline intervention. Detailed information, including the recruitment process and methodology, is expected in future updates from the sponsors. As of November 2025, the study is classified as “Not yet recruiting,” implying imminent progress once preparatory stages are finalized.
Sponsorship for this trial comes from Anabio R&D and Hanoi Medical University. Both parties bring expertise for rigorous investigation into new healthcare solutions, focusing on safety, effectiveness, and adherence to clinical and regulatory standards.
How might probiotic oral spray help children?
Probiotic oral sprays are designed to restore balance in the oral microbiome, potentially reducing harmful bacteria and promoting healthier oral environments. Bacillus spore probiotics are known for their stability and ability to withstand harsh conditions, making them suitable for dental applications. Smile Care aims to act on bacterial colonies that contribute to caries, offering an innovative option for pediatric dental care.
If proven effective, this approach could decrease reliance on traditional interventions such as fluoride treatments or mechanical removal of decay, which may be cumbersome for pediatric populations.
FAQ
1. Who are the sponsors?
Anabio R&D and Hanoi Medical University are jointly sponsoring this clinical trial.
2. What is Smile Care?
Smile Care is a combination product based on probiotics that aims to support prevention and treatment of dental caries.
3. Can probiotics replace traditional treatments?
While probiotics are a promising option, they are currently considered complementary as research on their effectiveness continues.
4. When does recruitment start?
The study has not yet started recruiting participants as of November 2025.
Key takeaways
This clinical trial represents an important development in modern dental care by investigating Bacillus spore probiotics as a tool for preventing and managing dental caries in children. Professionals in clinical and regulatory sectors should keep track of this study’s progression for potential new solutions in pediatric oral health management.
Disclaimer
Content provided here is for informational purposes only and does not constitute legal or regulatory advice. Always consult the relevant authorities or legal professionals for specific guidance.
Full announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07241052?term=medical+device